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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 7 October 2014
Main ID:  EUCTR2013-005363-52-NL
Date of registration: 27/03/2014
Prospective Registration: Yes
Primary sponsor: Department of Neurology, Academic Medical Center
Public title: Intravenous immunoglobulin overtreatment in CIDP
Scientific title: Intravenous immunoglobulin overtreatment in chronic inflammatory demyelinating polyneuropathy (CIDP)
Date of first enrolment: 10/09/2014
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005363-52
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Continuation of current intavenous immunoglobulin treatment Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Netherlands
Contacts
Name: Clinical Trial office    
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: 312056667692
Email:
Affiliation:  Department of Neurology, Academic Medical Center
Name: Clinical Trial office    
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: 312056667692
Email:
Affiliation:  Department of Neurology, Academic Medical Center
Key inclusion & exclusion criteria
Inclusion criteria:
1) Probable or definite CIDP according to the EFNS/PNS criteria 20103
2) Stable disease for 6 months (e.g. no progression of disease in last 6 months)
3) IVIg treatment for at least 6 months
4) IVIg infusion interval of 2 to 6 weeks.
5) Age > 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
1) Deterioration after IVIg withdrawal in the last 12 months
2) Changes in IVIg treatment dose/interval in last 6 months
3) Change of additional CIDP treatment, if any, in the last 3 months (e.g. corticosteroids or immunosuppressive treatment)
4) A prolonged period (> 6 weeks) of disability increase following an earlier IVIg withdrawal attempt
5) History of respiratory failure related to CIDP
6) Legally incompetent
7) Lack of written informed consent



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Sodium Chloride 0.9%
Product Name: Sodium Chloride 0.9%
Product Code: RVG 51680
Pharmaceutical Form: Solution for infusion

Pharmaceutical Form: Solution for infusion

Primary Outcome(s)
Main Objective: The primary objective is to determine whether subjects with CIDP are overtreated with maintenance IVIg treatment and to reduce overtreatment-associated subjects’ burden and health care costs.
Primary end point(s): For the primary outcome we will use the Rasch-Overall Disability Scale (R-ODS), a patient self-report linearly weighted scale that measures activity and social participation limitations.
Secondary Objective: Secondary objective is to search for possible explanatory factors of ongoing need of IVIg treatment.
Timepoint(s) of evaluation of this end point: At 24 weeks or at a predefined early end-point. Participants will reach an early endpoint if they deteriorate on the R-ODS by more than 0.652 logits during follow-up.
Secondary Outcome(s)
Secondary end point(s): 1) The proportion of subjects remaining stable on their individual R-ODS score and completing the follow-period. An individual subject will be considered stable if the difference between his or her baseline and endpoint R-ODS scores is less than 0.652 logits.
2) Muscle strength using the Medical Research Council (MRC) sum score of 12 predefined muscle groups (range 0 to 60, including shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and foot dorsiflexion).
3) Grip strength, measured in kPa by a Martin-Vigorimeter.
4) Sensory impairment using the modified INCAT Sensory Sum Score (INCAT–SS, range 0-20).
5) Subject’s perception of clinical deterioration on a 5-point Likert scale.
6) Disase-non-specific disability using the AMC Linear Disability Scale (ALDS, range 0 [dead] to 100 [fully able]).
7) Quality of life using Short Form-36 (SF-36).
8) Pain using the Pain-Intensity Numerical Rating Scale (PI-NRS, a 11-point scale).
9) Fatigue using a 7-item linear modified Rasch-built fatigue scale.
10) Costs of health care use, costs of production loss, and out-of-pocket expenses.
11) Difference between serum IgG levels before and after last IVIg infusion prior to first study treatment.
Timepoint(s) of evaluation of this end point: At 24 weeks or at a predefined early end-point. Participants will reach an early endpoint if they deteriorate on the R-ODS by more than 0.652 logits during follow-up.
Secondary ID(s)
IOCtrial
Source(s) of Monetary Support
Sanquin Blood Supply Foundation
ZonMw
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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